Device for expanding and supporting body tissue

ABSTRACT

An expandable device for expanding and supporting body tissue comprises an inferior endplate having an outer surface configured to contact one body tissue surface and a superior endplate having an outer surface configured to contact an opposing body tissue surface. The inferior endplate and the superior endplate are movable relative to each other in a direction of expansion. The device includes an elevator captively supported between the inferior endplate and the superior endplate for independent movement along the direction of expansion. In the first direction the elevator is moved toward said superior endplate to lift the superior endplate and expand the device. In the second direction the elevator moves away from said superior endplate toward said inferior endplate to create a space for insertion of an insert into the expanded device.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/736,689, filed Jun. 11, 2015, now U.S. Pat. No. 9,445,921, which is acontinuation-in-part application of U.S. application Ser. No.14/474,555, filed Sep. 2, 2014, now U.S. Pat. No. 9,078,767, whichclaims the benefit of U.S. Provisional Patent Application No.61/948,645, filed Mar. 6, 2014, each of which is herein incorporated byreference in its entirety.

FIELD OF THE INVENTION

The subject invention relates generally to the field of surgery, andparticularly to surgical devices, instruments and methods of using thesame.

BACKGROUND OF THE INVENTION

A variety of physical conditions involves two bodily tissue surfacesthat, for treatment of the condition, need to be separated from oneanother and supported away from one another. Such tissue expansion maybe to gain exposure to select tissue structures, to apply a therapeuticpressure to select tissues, to return tissue structures to theiranatomic position and form, or in some cases to deliver a drug or growthfactor to alter, influence or deter further growth of select tissues.Depending on the condition being treated, the tissue surfaces may beopposed or contiguous and may be bone, skin, soft tissue, or acombination thereof.

One particular device for treating these conditions by distracting andsupporting tissue surfaces simultaneously is described in U.S. Pat. No.6,595,998, entitled “Tissue Distraction Device”, which issued on Jul.22, 2003 (the '998 Patent). Other examples of such tissue distractingand supporting devices that are used for achieving spinal interbodyfusion are described in U.S. Pat. No. 7,931,688 entitled “ExpandableInterbody Fusion Device”, which issued on Apr. 26, 2011 (the '688Patent), and U.S. Pat. No. 7,967,867 entitled “Expandable InterbodyFusion Device”, which issued on Jun. 28, 2011 (the '867 Patent). The'998 Patent, the '688 Patent and the '867 Patent each disclosessequentially introducing in situ a series of elongate inserts referredto as wafers in a percutaneous approach to incrementally distractopposing vertebral bodies to stabilize the spine and correct spinalheight, the wafers including features that allow adjacent wafers tointerlock in multiple degrees of freedom. The '998 Patent, the '688Patent and the '867 Patent are assigned to the same assignee as thepresent invention, the disclosures of these patents being incorporatedherein by reference in their entirety.

An issue that has arisen regarding such interbody fusion devices thatuse inserts or wafers to incrementally expand such devices is thedetermination of when full expansion has been achieved as a result ofligamentotaxis and no further inserts may be inserted. It is thereforedesirable for a surgeon to know when a sufficient number of inserts hasbeen introduced to stabilize the spine and correct spinal height andwhether any additional inserts may be introduced. One approachaddressing this issue is described in commonly assigned U.S. Pat. No.8,828,019, entitled “Inserter for Expanding an Expandable InterbodyFusion Device”, issued on Sep. 9, 2014 (“the '019 Patent”) andincorporated herein by reference in its entirety.

Accordingly, in addition to interbody fusion applications, there is asimilar need for other applications that use an expandable device andinserter to insert such a device into body tissue and expand the devicein situ, including the capability to determine when proper expansion ofthe device has been achieved and no further inserts may be introduced.

SUMMARY OF THE INVENTION

It is an object of the invention to provide an improved device to expandbody tissue and to introduce inserts after the device has been expanded.A further object is to provide an inserter that has the capability ofallowing a surgeon to determine that suitable expansion has been reachedand no additional inserts may be inserted.

DESCRIPTION OF THE FIGURES

FIG. 1a is a top perspective of an apparatus including an inserterreleasably attached to an expandable spinal interbody fusion device inaccordance with an embodiment of the present invention, the expandableinterbody fusion device being unexpanded.

FIG. 1b is a side elevation view of the apparatus of FIG. 1 a.

FIG. 1c is a top plan view of the apparatus of FIG. 1 a.

FIG. 2 is an enlarged view of the distal portion of the apparatus ascircled in FIG. 1 c.

FIG. 3a is top perspective view of the unexpanded fusion device of FIG.1 a.

FIG. 3b is top perspective view of the fusion device of FIG. 3 afterbeing expanded.

FIG. 4 is an exploded top perspective view of the expanded device ofFIG. 3 b.

FIG. 5a is a side elevation view of the expanded device of FIG. 3 b.

FIG. 5b is a sectional view of the device of FIG. 5a as seen alongviewing lines B-B of FIG. 5 a.

FIG. 5c is a sectional view of the device of FIG. 5a as seen alongviewing lines C-C of FIG. 5 a.

FIG. 6a is a top perspective view of an insert used in the expandablespinal interbody fusion device of FIG. 3 a.

FIG. 6b is a top plan view of the insert of FIG. 6 a.

FIG. 6c is a longitudinal cross-sectional view of the insert as seenalong viewing lines VI-VI of FIG. 6 b.

FIG. 6d is a bottom plan view of the insert of FIG. 6 a.

FIG. 6e is a distal end elevation view of the insert of FIG. 6 a.

FIG. 7a is a top perspective view of an elevator used in the expandablespinal interbody fusion device of FIG. 3 a.

FIG. 7b is a top plan view of the elevator of FIG. 7 a.

FIG. 7c is a longitudinal cross-sectional view of the elevator as seenalong viewing lines VII-VII of FIG. 7 b.

FIG. 7d is a bottom plan view of the elevator of FIG. 7 a.

FIG. 7e is a distal end elevation view of the elevator of FIG. 7 a.

FIG. 8 is an exploded top perspective view of the track and componentsof the inserter of FIG. 1a , including the translatable lifting platformand translatable driver.

FIG. 8a is an enlarged view of the distal portion of the inserter trackand components as circled in FIG. 8.

FIG. 9 is a cross-sectional view of the inserter and device of FIG. 1aas seen along viewing lines IX-IX of FIG. c.

FIG. 9a is an enlarged view of the encircled portion A of FIG. 9.

FIG. 9b is an enlarged view of the encircled portion B of FIG. 9.

FIG. 10a is a cross-sectional view of the distal end of the inserter anddevice as seen along viewing lines A-A of FIG. 2 with the expandabledevice unexpanded.

FIG. 10b is a cross-sectional view of the distal end of the inserter anddevice as seen along viewing lines B-B of FIG. 2 with the expandabledevice unexpanded.

FIG. 11 is a top partial perspective view of the distal end of thelifting platform and the elevator of the expandable device in theposition depicted in FIGS. 10a and 10 b.

FIG. 12 is a cross-sectional view of the lifting platform and elevatoras seen along viewing lines XII-XII of FIG. 11.

FIGS. 13a and 13b are views similar to FIGS. 10a and 10b with thelifting platform having been distally moved to a position lifting theelevator and expanding the expandable device and a first insertpartially entering the expanded device.

FIG. 14 is a view similar to FIG. 10a showing the first insert insertedinto the expanded expandable device.

FIGS. 15a and 15b are views similar to FIGS. 13a and 13b with thelifting platform having been moved distally to a position lifting theelevator and the first insert to further expand the expandable devicewith a second insert partially entering the expanded device.

FIGS. 16a and 16b are views of the expandable device expanded as shownin the views of FIGS. 15a and 15b with the second insert having beenfurther distally moved to a position moving the elevator away from thefirst insert and creating a space for the insertion of the secondinsert.

FIG. 17 is a view similar to the view of FIG. 14 showing the first andsecond inserts inserted into the expanded expandable device.

FIG. 18 is a cross-sectional view as seen along the viewing linesXVIII-XVIII of FIG. 17.

FIG. 19 is a proximal perspective view of the expanded spinal interbodyfusion device with a guide pin releasably connected thereto subsequentto the inserter having been detached from the guide pin with inserts notbeing shown for clarity.

FIG. 20 is a top perspective of an apparatus including an inserterreleasably attached to an expandable spinal interbody fusion device inaccordance with a further embodiment of the present invention with theinserter being modular.

FIG. 21 shows a vertebral body having a compression fracture displacingits superior and anterior edge.

FIG. 22 shows a vertebral body, following treatment of a compressionfracture.

FIG. 23 illustrates a plan view of an insertion apparatus according toanother embodiment of the invention, placed within a vertebral body ofFIG. 21, shown in cross-section.

FIG. 24 shows a side view of the insertion apparatus of FIG. 23 beingdeployed within a vertebral body, shown in sectional view.

DESCRIPTION OF THE EMBODIMENTS

For the purposes of promoting and understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and described in the following written specification. It isunderstood that no limitation to the scope of the invention is therebyintended. It is further understood that the present invention includesany alterations and modifications to the illustrated embodiments andincludes further applications of the principles of the invention aswould normally occur to one skilled in the art to which this inventionpertains.

The invention provides a combination of an implantable expansion andsupport device and instrumentation to place the device into body tissue.The application of the invention as a spinal implant in spinal interbodyfusion is detailed initially. Turning now to FIGS. 1a-c , 2, 3 a-b and4, an apparatus 1 for use in spinal interbody fusion is shown. Apparatus1 comprises an expandable spinal interbody fusion device 10 and aninserter 100. The inserter 100 is an instrument used for inserting thedevice 10 into an intradiscal space between opposing vertebral bodies ofa spine, expanding the device in situ and for inserting inserts into theexpanded device 100. The expandable interbody fusion device 10 includesa first element, such as superior endplate 12, a second element, such asinferior endplate 14, at least one insert 16 and expansion structureincluding an elevator 18, as will be detailed hereinbelow. The height,H, across the superior and inferior endplates 12, 14 in the unexpandedcondition as illustrated in FIG. 1b is less than the normal anatomicheight of a typical intradiscal space. The invention contemplatesexpanding the interbody fusion device 10 by the inserter 100 from anunexpanded condition as shown in FIG. 3a to the expanded height as shownin FIG. 3b to ultimately restore the normal anatomic height of the discspace and thereafter inserting one or more inserts, such as inserts 16,as will be described, to form a stack of inserts 16 between the expandedsuperior endplate 12 and inferior endplate 14. In the particulararrangement being described, fusion device 10 is configured and sizedfor implantation into the spine from the posterior approach. In theunexpanded state as shown in FIG. 3a , device 10 has a length ofapproximately 25 mm, a width of approximately 10 mm, and an unexpandedheight H of approximately 7 mm. Fusion device 10 may also be configuredand sized for implantation into the spine using posteriolateral,anterior or lateral approaches, as will be described.

The superior endplate 12 as shown in FIGS. 3a-b and 18 is elongate andcomprises a hub 20 having pair of side surfaces 22 and 24 extendinglongitudinally on each side of the hub 20 and a pair of end surfaces 26and 28 extending respectively at the proximal rear end and the distalfront end of the superior endplate 12. The hub 20 is sized andconfigured to fit within a cavity 48 of the inferior endplate 14 fortelescoping movement therewithin, as will be described. The lowersurface 30 of the hub 20 (FIG. 18) is generally flat and planar.Suitable friction or crush ribs may be provided between the hub 20 andcavity 48 of inferior endplate 14 at inner surface 44 a to temporarilyhold the superior and inferior endplates 12, 14 together in thedirection of expansion as the device 10 is introduced into theintradiscal space to be distracted.

With continued reference to FIGS. 3a-b and 18, the superior endplate 12includes a graft chamber defined by an opening 38 extending through theupper outer surface 12 a and the lower surface 30. In accordance withone arrangement, the superior endplate 12 is formed of a biocompatiblepolymer such as polyethylethylketone (PEEK). PEEK is used in fusionapplications for its combination of strength, biocompatibility, andelasticity which is similar to human bone. Other composites may includederivatives of PEEK such as carbon fiber reinforced PEEK and PEKK,respectively. In a particular aspect, the superior endplate 12 mayfurther include an upper endcap that defines the outer surface 12 a. Theendcap may be a separate plate formed of material for the promotion ofbone growth, such as titanium, and may be attached to the endplate 12with suitable conventional techniques. As an alternative, the uppersurface 12 a may be defined by a coating of a suitable layer of bonegrowth promotion material, such as titanium, which may be deposited byconventional techniques.

The inferior endplate 14 of the interbody fusion device 10 as shown inFIGS. 3a-b and 18 is elongate and comprises a pair of opposing spacedapart sidewalls 40 and 42 extending along the longitudinal direction andprojecting upwardly from the lower outer surface 14 a. A pair of spacedapart end walls 44 and 46 extend laterally across the device 10 andproject upwardly from outer surface 14 a. Rear end wall 44 is disposedat the rear or proximal end of the device 10 and front end wall 46 isdisposed at the front or distal end of the device 10. The side walls 40,42 together with rear end wall 44 and front end wall 46 form an open,upwardly facing fully bounded interior cavity 48 as shown in FIGS. 3aand 4. The interior cavity 48 is sized and configured to receive thesuperior endplate 12 including the hub 20 in relatively close fitbetween the side walls 40 and 42 and the end walls 44 and 46 of theinferior endplate 14 in a non-expanded condition as shown in FIGS. 1a-b. The hub 20 of superior endplate 12, as well as the entire stack ofinserts 16, remains fully contained within the inferior endplate 14during telescoping expansion of the device 10 as shown in FIGS. 18 and19, contributing to the torsional strength of the expanded device 10.

The inferior plate 14 as shown in FIGS. 4 and 19 includes a lower innersupport surface 54 on which elevator 18 is supported. Inner surface 54defines the bottom surface of the cavity 48. Inferior endplate 14further defines a fully bounded insert channel 50 extending through therear end wall 44 in communication with interior cavity 48 and throughwhich one or more inserts 16 are introduced. The height of channel 50 asmeasured vertically from inner surface 54 is slightly greater than thecombined thicknesses of insert 16 and elevator 18. With insert 16 beingslidably received through channel 50 on top of elevator 18, as will bedescribed, only one insert 16 may be introduced at a time. As device 10is expanded and further inserts 16 are sequentially introduced, allinserts 16 lying above the lowermost insert 16, which would be situatedon top of elevator 18, will be prevented from backing out of the device10 by the interior surface 44 a of rear end wall 44 (FIG. 4). The rearend wall 44 further defines a threaded connection opening 56 (FIG. 10a )for threaded releasable receipt of a guide pin 108 for use in theintroduction of inserts 16 and in the delivery of bone graft materialinto the device 10, as will also be described. Rear end wall 44 may alsoadditionally include a pair of bilateral openings, such as holes 58,adjacent the sidewalls 40 and 42 for use in releasably attaching theinserter 100 to the device 10 for the establishment of a rigidconnection to the device 10 for insertion into the intradiscal space.

Elevator 18 is supported on inner surface 54 of inferior endplate 14with the lateral width of elevator 18 being dimensioned for relativelyclose sliding fit between opposite interior surfaces 40 a and 42 a ofside walls 40 and 42, as shown in FIGS. 5c and 18. As such, lateralmovement of elevator 18 in directions transverse to the direction ofexpansion is substantially constrained. In addition, inferior endplate14 includes a rail 14 b projecting inwardly from each interior surface40 a and 42 a and upwardly from lower inner surface 54 toward superiorendplate 12. The upward projection of each rail 14 b from inner surface54 is slightly greater than twice the thickness of elevator 18. Rails 14b slidably project into recesses 310 extending into the base 305 ofelevator 18 at each lateral side. Rails 14 b substantially constrainmovement of elevator 18 in the axial direction while the clearance inrecesses 310 allows free movement of elevator 18 in the direction ofexpansion along rails 14 b as shown by the arrow 130 in FIG. 10a . Assuch, elevator 18 is captively supported within inferior endplate 14 andis independently movable along the direction of expansion toward andaway from each of the superior endplate 12 and the inferior endplate 14.

As shown particularly in FIGS. 4, 5 a-b and 18, the inferior endplate 14includes a graft chamber defined by an opening 60 extending through thelower outer surface 14 a and the lower inner surface 54 in communicationwith cavity 48. In accordance with one arrangement, the inferiorendplate 14 is formed of a material different from the material of thesuperior endplate 12. In this aspect, the inferior endplate 14 may beformed of a biocompatible metal, such as titanium, for its strengthproperties. Titanium is chosen for strength, biocompatibility,processing capability, and fluoroscopic imaging properties(radiolucency). Other alternative materials include cobalt chrome,stainless steel (both stronger than titanium but much less radiolucent),or biocompatible ceramics such as silicon nitride or zirconia, which areradiolucent. Titanium and silicon nitride have demonstrated goodapposition to bone and superiority to PEEK. In this regard whereinferior endplate 14 is formed of titanium, the lower outer surface 14 awould provide for the promotion of bone growth. Lower outer surface 14 amay also, however, be coated with a suitable layer of bone growthpromotion material, such as titanium, and deposited in a conventionalmanner so as to match the roughness/porosity of the superior endplateouter surface 12 a.

Where inferior endplate 14 is formed of titanium or other suitable metalthat is radiopaque, windows 62 may be formed through sidewalls 40 and 42as shown in FIGS. 3a-b and 19 so as to allow visual observation of bonythrough growth by suitable imaging techniques, such as fluoroscopy.Further details of interbody fusion device 10 are described in commonlyassigned U.S. Pat. No. 8,900,312, patent application Ser. No. 13/795,054entitled “Expandable Interbody Fusion Device with Graft Chambers”, filedon Mar. 12, 2013 (“the '312 Patent”) and incorporated herein byreference in its entirety.

Details of insert 16 are shown in FIGS. 6a-e . The insert 16 comprisesan elongate and generally flat body 200 having an upper surface 202 anda lower surface 204, both of which are generally planar andsubstantially parallel so that the inserts 16 can form a stable stackwithin the interbody fusion device 10 upon expansion. Insert 16 includesa trailing rear proximal end 206 and a leading front distal end 208. Thebody 200 is formed to have a generally U-shaped, horseshoeconfiguration, with a pair of spaced opposing arms 212 and 214projecting rearwardly from a base 205 and defining a rearwardly facinggenerally U-shaped opening 216 extending through the rear end 206 andthrough upper surface 202 and lower surface 204. The lateral width ofbody 200 between side surfaces 212 a and 214 a is dimensioned for arelatively close sliding fit between interior surfaces 40 a and 42 a ofside walls 40 and 42 of inferior endplate 14, as shown in FIG. 5b . Suchclose dimensioning reduces the potential of lateral movement of insert16 during insert introduction and within cavity 48 of inferior endplate14. A surface 218 between the upper surface 202 and the lower surface204 at the base 205 of opening 216 defines a pushing surface for receiptof a driver of inserter 10, as will be described. The opening 216 at therear end of each insert 200 is provided to allow bone graft material toflow into the device 10 through the insert openings 216 and into theopenings 38 and 60 extending through the superior endplate 12 and theinferior endplate 14, respectively. A pair of inclined surfaces 208 aextends upwardly from and communicating with lower surface 204 on eachlateral side the insert 16 adjacent the front distal end 208.

The insert 16 includes a feature for interlocking engagement withelevator 18 in a complementary cooperative connection. Distal front end208 of insert body 200 includes therein a latching receptacle 220defined by a pair of spaced opposing arms 222 a and 222 b for receipttherein of a flexible latch 318 (FIG. 7a-e ) on elevator 18, as will bedescribed. Arms 222 a and 222 b include inwardly projecting lockingsurfaces 224 a and 224 b respectively for cooperative locking engagementwith elevator latch 318. Unlike the inserts described in the '312Patent, the inserts 16 described herein do not function to assist in theseparation of superior endplate 12 and inferior endplate 14 or anysubsequent inserts 16 inserted into interbody fusion device 16, as thatlifting function is provided herein by inserter 100 in conjunction withelevator 18. It is contemplated that the inserts 16 described herein beformed of a biocompatible material that is sufficiently rigid to form asolid stack as the successive inserts are inserted into the device.Thus, in one specific embodiment, the inserts 16 are formed of PEEK or acarbon-fiber reinforced PEEK, or similar polymeric material.

Turning now to FIGS. 7a-e , details of the elevator 18 are shown. Theelevator 18 comprises an elongate and generally flat body 300 having anupper surface 302 and a lower surface 304, both of which are generallyplanar and substantially parallel. The elevator 18 has a thicknessbetween upper surface 302 and lower surface 304 that is slightly greaterthan the thickness of insert 16. As such, when as noted below thethickness of an insert 16 is, for example, 1.0 mm, the thickness ofelevator 18 may be 1.03 mm. Elevator 18 includes a trailing rearproximal end 306 and a leading front distal end 308. The elevator body300 is formed to have a generally U-shaped, horseshoe configurationsimilar to the configuration of insert 16. Elevator body 300 includes apair of spaced opposing arms 312 and 314 projecting rearwardly from abase 305 and defining a rearwardly facing generally U-shaped opening 316extending through the rear end 306 and through upper surface 302 andlower surface 304. Base 305 has a rearwardly facing surface 305 a thatcommunicates with opening 316. The opening 316 at the rear end ofelevator 18 is provided to allow bone graft material introduced into thedevice 10 to flow through the insert openings 216 of inserts 16 and intothe openings 38 and 60 extending through the superior endplate 12 andthe inferior endplate 14, respectively. The rear proximal end 306includes an inclined surface 312 a and 314 a, respectively at the freeend of each arm 312 and 314 extending downwardly from and communicatingwith the upper surface 302. The rear proximal end 306 further includesan inclined lifting surface 312 b and 314 b, respectively at the freeend of each arm 312 and 314 extending upwardly from and communicatingwith the lower surface 304. The front distal end 308 includes adjacentbase surface 305 a an inclined lifting surface 308 a extending upwardlyfrom and communicating with lower surface 304. The inclined liftingsurfaces 312 b, 314 b and 308 a are angled in the same direction withapproximately equal angles. The lifting surfaces 312 b, 314 b and 308 adefine inclined ramps with multiple points of contact for cooperativecontact with complementary surfaces of an expansion component on theinserter 100 for lifting elevator 18, as will be described. Inclinedsurface 308 a is generally centrally located along the elongate axis ofelevator, while surfaces 312 b and 314 b are spaced bilaterally. Thus,lifting surfaces 308 a, 312 b and 314 b define three triangulated pointsof contact. Elevator has a recess 310 extending into the elevator base305 at each lateral side thereof. Recesses 310 are sized to receiverails 14 b on the interior surfaces of inferior endplate 14, asdescribed. In one specific embodiment, the elevator 18 is formed oftitanium alloy, type 2, which may be anodized for lubricity. Othermaterials, such as PEEK, may also be used as the material for elevator18.

Distal front end of elevator body 300 includes a flexible latch 318projecting upwardly from upper surface 302. Latch 318 comprises a pairof spaced opposing flexible arms 320 a and 320 b that are configured toflex toward each other. Flexible arms 320 a and 320 b include outwardlydirected locking surfaces 322 a and 322 b respectively, for cooperativereceipt within receptacle 220 of each insert 16, as shown in FIG. 5b .Upon receipt of latch 318 into receptacle 220, locking surfaces 224 aand 224 b resiliently engage locking surfaces 322 a and 322 b,respectively. Latch 318 projects above the upper surface 302 and aheight slightly greater than the thickness of an insert 16. The lateralwidth of elevator body 300 between the side surfaces 312 c and 314 c,respectively of arms 312 and 314 is dimensioned for a relatively closesliding fit as noted hereinabove between interior surfaces 40 a and 42 aof inferior endplate 14, as shown in FIG. 5 c.

Turning again now to FIGS. 1a-c and FIGS. 8 and 8 a, details of theinserter 100 are described. Inserter 100 is elongate having a distal end100 a and at a proximal end 100 b a frame 101. A trigger actuator 102 toeffect expansion of device 10 and insertion of inserts 16 into device 10after expansion includes a frame 101 at the proximal end 100 b ofinserter. A plurality of inserts 16 are movably supported in a lineararray on an elongate track 104 for individual successive insertion intodevice 10. Track 104 supports at least one insert 16 and may, forexample, support an array of five inserts 16, although fewer or moreinserts 16 may be supported as desired.

The distal end 100 a is shown in exploded detail in FIGS. 8 and 8 a. Theinserter 100 includes elongate track 104 and an outer elongate trackcover 106, the cover 106 being substantially rigidly joined to track104. Track 104 is configured as a closed channel and is supported withinouter track cover 106. Cover 106 is fixedly secured to frame 101,although in a particular arrangement as will be described, cover 106 maybe removably attached to frame 101. An elongate guide pin 108 issupported within an opening 110 extending lengthwise through the cover106. The distal end 108 a of the guide pin 108 is threaded forreleasable threaded engagement into opening 56 in the proximal rear endwall 44 of the inferior endplate 14. The proximal end of guide pin 108is provided with a threaded knob 112 for compressing and releasablyattaching the cover 106, and thereby the track 104 to the device 10. Thetrack cover 106, in one arrangement, includes a pair of opposing pins114 that engage corresponding holes 58 in rear wall 44 of inferiorendplate 14 (FIG. 19) to assist in rigidly securing the inserter 100 tothe device 10. It should be appreciated that other securement structuremay be used to releasably attach the inserter 100 to the device 10.Track 104, in one embodiment, is formed of stamped stainless steel andcover 106 is an extruded aluminum alloy. Stainless steel or strongreinforced plastic could also be used for cover 106.

The track 104 at the distal end 100 a of the inserter 100 supports anexpansion component defined by an axially translatable lifting platform116 movably supported on track 104 for relative axial movement theretoto cooperatively slidably contact elevator 18 for expanding the device10. The lifting platform 116 is elongate and generally flat having anupper surface 118 and a lower surface 120, both of which are generallyplanar and substantially parallel (FIG. 18). The lifting platform 116has a thickness between upper surface 118 and lower surface 120 that isdimensioned to be the same as the thickness of elevator 18, i.e.,slightly greater than the thickness of an insert 16. Lifting platform116 is supported by the inserter 100 for reciprocating axial movement inprojecting and retracting directions. The proximal end of the liftingplatform 116 d is coupled to the trigger actuator 102 to effect suchprojecting and retracting directions, as will be described.

Lifting platform 116 projects slidably axially outwardly from track 104and includes at its free distal end an inclined lifting surface 116 aextending downwardly from and communicating with upper surface 118. At alocation spaced proximally of lifting surface 116 a, lifting platformfurther includes a pair of laterally spaced inclined surfaces 116 b and116 c. The inclined lifting surfaces 116 a, 116 b and 116 c are angledin the same direction with angles approximately equal to the anglesrespectively of inclined lifting surfaces 312 b, 314 b and 308 a ofelevator body 300. Inclined surfaces 116 a, 116 b and 116 c defineinclined ramps with multiple complementary points of contact forcooperative contact with elevator 18. Inclined surface 116 a isgenerally centrally located along the elongate axis of lifting platform116, while surfaces 116 b and 116 c are spaced bilaterally. Thus,lifting surfaces 116 a, 116 b and 116 c define three triangulated pointsof contact that are located and spaced to cooperatively contact liftingsurfaces 308 a, 312 b, and 314 b, respectively during movement oflifting platform 116 in the projecting direction. Lifting platform 116,particularly inclined surfaces 116 a, 116 b and 116 c, may be coated orotherwise include a suitable lubricant to facilitate sliding contactwith elevator 18 for expansion of device 10. Where lifting platform 116is made of stainless steel, for example, such lubricant may include amolybdenum disulfide (MoS₂) material.

Still referring to FIGS. 8 and 8 a, inserter 100 further supports at itsdistal end 100 a a driver 124 for axial translational movement withintrack 104. The proximal end 124 a (FIG. 8) of driver 124 is coupled totrigger actuator 102 to effect translational movement of the driver 124,as will be described. The distal end of driver 124 comprises a pushingsurface 124 b sized and configured to enter into the opening 216 of aninsert body 200 to engage pushing surface 218 and push the insert 16from track 104 into the device 10 upon axial distal movement of driver124. Furthermore, driver 124 includes an upper surface 124 c on whichinserts 16 are movably supported in a linear array. Also included asshown in FIG. 8 is an indexing member 125 that cooperates with driver124 to distally incrementally move inserts 16 in the projectingdirection to be positioned for individual contact with driver pushingsurface 124 b while preventing retrograde movement of inserts 16 as theyare positioned.

With further reference still to FIG. 8a , inserter 100 comprises aflexible graft shield 128 projecting distally from inner track 104.Graft shield 128 is supported at one end 128 a in a cantilevered mannerwith an opposite end 128 b being unsupported and free to flex. Graftshield 128 is elongate and generally flat and is sized and configured tosubstantially block communication between the opening 38 through thesuperior endplate 12 and inserts 16 slidably inserted into device 10. Aswill be described, graft shield 128 is configured to extend into device10 through channel 50 between the superior endplate 12 and the expansionstructure adjacent the lower surface 30 of the superior endplate 12.

Turning now to FIGS. 9 and 9 a-b, the details of the trigger actuator102 of the inserter 100 and its operating mechanism and function aredescribed. Trigger actuator 102 comprises a pair of hand grips 132 and134 biased apart by an extension spring 136. Hand grip 132 is fixedlysecured to frame 101 of inserter 100. Hand grip 134 is pivotallyconnected to frame 101 at pivot point 138 and is movable toward handgrip 132 against the bias of extension spring 136 by manual pressure.Hand grip 134 has gear teeth 140 that interface with a gear rack 146slidably coupled to the frame 101. The gear mechanism is sized toprovide the appropriate translation of the gear rack 146 in theprojecting direction as trigger actuator 102 is actuated. Also slidablycoupled to the frame 101 are a driving slide 150 that is configured forrelative and joint movement with driver 124, and a lifting slide 154that is configured for joint movement with lifting platform 116. Gearrack 146 includes a lower surface 146 a defining a tooth pattern, anupper surface 146 b defining a pushing surface 146 d, a ramp surface 146e, and a distal end 146 c. Distal end 146 c includes a pawl 148configured for limited rotation about pivot point 148 a, the distal endof pawl 148 being biased toward the driving slide 150 by a compressionspring 152. Prior to actuation of trigger 102 the pawl 148 isconstrained from rotation about pivot point 148 a by the lower surface150 a of driving slide 150. Upon a first actuation of trigger 102, andtherefore translation of the gear rack 146 in the projecting direction,the pawl 148, under bias of compression spring 152, slides along lowersurface 150 a. When sufficient translation of gear rack 146 has occurredsuch that the pawl 148 has passed the distal end of driving slide 150,pawl 148 rotates counterclockwise as viewed in FIG. 9a about pivot point148 a to a position limited by contact with upper surface 146 f of gearrack 146.

Pawl 148 includes a pushing surface 148 b sized to engage pushingsurface 154 a at proximal end of lifting slide 154. Further actuation ofthe trigger 102 promotes contact of pushing surfaces 148 b and 154 a andtherefore movement of the lifting slide 154 and lifting platform 116 inthe projecting direction causing expansion of the device 10.

Lifting slide 154 further includes a proximal elongate tethering portion154 b with pushing surface 154 c sized to engage pushing surface 150 bat proximal end of driving slide 150. Upon translation of lifting slide154 in the projecting direction, pushing surface 154 c engages pushingsurface 150 b for joint translation therebetween.

Driving slide 150 further includes an upper boss feature 156 definingpushing surfaces 156 a and 156 b sized to fit within slot a 124 d (FIG.8) of driver 124. Slot 124 d comprises complementary axially spacedapart pushing surfaces 124 e and 124 f, respectively. The length of slot124 d is sized such that translation of driving slide 150 during firstactuation of trigger 102 does not induce contact between pushingsurfaces 156 b and 124 f and therefore does not impart translation ofdriver 124.

Driving slide 150 further includes a pawl 158 configured for limitedrotation about pivot point 158 a, the proximal end of pawl being biasedtoward the gear rack 146 by bilateral torsion springs (not shown). Priorto actuation of trigger 102 the pawl 148 is constrained from rotationabout pivot point 158 a by a ledge surface 160 rigidly coupled to frame101. Upon translation of the driving slide 150 in the projectingdirection, the pawl 158, under bias of the torsion springs, slides alongupper ledge surface 160. When sufficient translation of driving slide150 has occurred such that the pawl 158 has passed the distal end ofledge surface 160, pawl 158 rotates counterclockwise as viewed in FIG.9a about pivot point 158 a to a position limited by contact with lowersurface 150 c of driving slide 150. Such translation is configured to beslightly longer than the translation required by the lifting platform116 to achieve full expansion of device 10 such that rotation of pawl158 will not occur in the absence of full expansion of device 10.Further, rigidly coupled to pawl 158 for rotation therewith arebilateral flags 162 positioned in slots 163 in frame 101 (FIG. 1a ), theflags 162 projecting laterally outwardly of both sides of frame 101.Upon joint rotation of pawl 158 and flags 162 the user is visuallyalerted to the position of the driving slide 150 and lifting slide 154thereby indicating to the user that full expansion of device 10 has beenachieved and that no further inserts can be introduced.

Pawl 158 further comprises a pushing surface 158 b sized to engagepushing surface 146 d of gear rack 146 and a ramp surface 158 c sized toengage ramp surface 146 e of gear rack 146. After full actuation and acomplete stroke of trigger 102 and release of grip pressure, the gearrack 146 and hand grips 132/134 are returned under the bias of theextension spring 136. During retraction of the gear rack 146,cooperative ramp surfaces 146 e and 158 c collide inducing pawl 158 torotate clockwise thereby allowing passage of the gear rack 146. Uponsufficient translation of the gear rack 146 in the retracting directionsuch that the ramp surface 146 e has passed the proximal edge of ramp158 c, pawl 158 rotates counterclockwise about pivot point 158 a back toa position limited by contact with lower surface 150 c of driving slide150.

It should be appreciated that upon completion of first actuation oftrigger 102 and completion of the first stroke, lifting platform 116remains projected maintaining the expanded state of device 10 and thatdriving slide 150 remains in a partially projected state due to tether154 b of lifting slide 154. It should also be noted that pawl 158remains in a rotated state limited by contact with driving slide 150while pawl 148 is returned to its original collapsed state limited bylower surface 150 a of driving slide 150.

Upon a second actuation of trigger 102 gear rack 146 translates again inthe projecting direction such that pushing surface 146 d contactspushing surface 158 b of pawl 158 causing joint translation of gear rack146 and driving slide 150. Upon further actuation, pushing surface 156 bof driving slide 150 contacts pushing surface 124 f of driver 124causing joint translation therebetween, thereby engaging pushing surface218 of insert 16 and pushing the insert 16 from track 104 into thedevice 10 during completion of the second stroke of trigger actuator102.

For the purpose of returning the track lifting platform 116 to itsoriginal position in the retracting direction a cam 164 and gear 166 areprovided. The gear 166 interfaces with a second gear rack 154 d rigidlyconnected to the lower surface of lifting slide 154. The cam 164 iscoupled to gear 166 for opposite rotation therebetween and is positionedto contact a notch 170 (FIG. 8a ) in the driver 124 after an insert 16has been partially inserted into the device 10. Further triggeractuation returns the lifting platform 116 to its original positionwhile the driver further inserts the insert 16. When full triggeractuation is achieved, the gear rack 146 and hand grips 132/134 arereturned under the bias of the extension spring 136. To reset theposition of driving slide 150 manually, the user pulls up on bilateraltabs 162 b rigidly coupled to flags 162 thereby imparting rotation ofpawl 158 and translation of driving slide 150 in the retractingdirection. Due to the rotated state of flags 162 and pawl 158, driverslide 150 can be returned to its original retracted position with pawl158 rotation limited by ledge 160 surface. A two way ratchet mechanism168 prevents unwanted motion of driving slide 150 in the wrongdirection. In the event full expansion of device 10 is achieved and thesurgeon prefers to abort the procedure without further introduction ofan insert 16, hex fitting 174 (FIG. 1a ) coupled to gear 166 may beactuated by a hex wrench or other suitable tool. Rotation of fitting 174rotates gear 166 which directly translates lifting slide 154 and hencelifting platform 116 proximally to release the expansion of device 10with no insert 16 introduced.

It should now be understood how the trigger actuator 102 operates toexpand device 10 and introduce one or more inserts 16. During the firststroke, only lifting platform 116 is translated in the projectingdirection to cause expansion of device 10. Driver 124 remains stationaryduring the entire first stroke. After the hand grips 132/134 arereturned to the starting position under the bias of extension spring 136upon completion of the first stroke, lifting platform 116 remainsstationary in the projecting position maintaining the expanded state ofdevice 10 as hand grips 132/134 return. During the second stroke oftrigger actuator 102, driver 124 is translated in the projectingdirection while the lifting platform 116 is initially stationary in theprojecting direction. When driver 124 has inserted an insert 16partially into the expanded device 10 continued operation of triggeractuator 102 retracts lifting platform 116 in the retracting direction.As lifting platform 116 retracts, driver 124 continues to advance in theprojecting direction to push insert 16 fully into position uponcompletion of the second stroke.

Thus, for the particular device being described for insertion into theintradiscal space in the posterior approach, expansion of device 10 isachieved during the first stroke of trigger actuator 102 and fullinsertion of an insert 16 during completion the second stroke. Forlonger devices, such as those insertable from the lateral approach, themechanism of inserter 100 may be adjusted such that the longer device isexpanded in a first stroke, the inserts 16 inserted partially into theexpanded device during a second stroke, and fully inserted in the thirdstroke. It should thus be appreciated by those skilled in the art thatthe number of strokes employed for expansion of device 10 and insertionof an insert 16 into the expanded device 10 may be varied by suitableadjustment of the operating mechanism of trigger actuator 102. Suchadjustment may include, for example, varying the number of pushingsurfaces 146 d that are provided on gear rack 146 for engagement withpawl 158.

Turning now to FIGS. 10a-b and 11-12 the assembly of the device 10 andthe inserter 100 is described. The superior endplate 12 and the inferiorendplate 14 are assembled in an unexpanded condition to the inserter 100with the superior endplate 12 residing fully within cavity 48 ofinferior endplate 14. In such condition elevator 18 is captivelyretained between superior endplate 12 and inferior endplate 14 asdescribed above and shown in FIG. 5c for independent movement along thedirection of expansion 130. The inserter 100 is releasably attached tothe device 10 upon threaded engagement of the guide pin 108 intothreaded opening 56 in the proximal rear end wall 44 of the inferiorendplate 14. Graft shield 128 extends into device 10 through channel 50between the superior endplate 12 and the elevator 18 adjacent the lowersurface 30 of the superior endplate 12. With the inserter 100 fixed tothe device 10, lifting platform 116 and driver 124 are axiallytranslatable relative to the device 10 in the projecting and retractingdirections. In this unexpanded condition, there are no inserts 16 in thedevice 10. In the arrangement being described, there are five inserts 16supported in a linear array on track 104.

In the position illustrated in FIGS. 10a-b and 11-12 lifting platform116 is in a retracted position relative to device 10 and elevator 18.Insert 16, as seen in FIG. 10a , is disposed on track 104 exteriorly ofand ready for insertion into device 10. In this position the lowersurface 120 of lifting platform 116 is situated on lower inner surface54 of inferior endplate 14. Likewise lower surface 304 of elevator 18 issupported by lower inner surface 54 of inferior endplate 14. As such,lifting platform 116 and elevator 18 are on substantially the sameplane, with the upper surface 118 of lifting platform 116 beingsubstantially coplanar with the upper surface 302 of elevator 18. Withthe inserter 100 attached to the device 10, elevator 18 is fixed in theaxial direction relative to axial movement of lifting platform 116.

In the condition shown in FIGS. 10a-b , apparatus 1 comprisingunexpanded device 10 releasably attached to inserter 100 is ready foruse in inserting device 10 into an intradiscal space between twoopposing vertebral bodies. Prior to insertion, opening 38 throughsuperior endplate 12 may be pre-packed with a suitable bone graftmaterial for the promotion of fusion through device 10 to the opposingvertebral bodies. Graft shield 128 extends into device 10 throughchannel 50 between the superior endplate 12 and the elevator 18 adjacentthe lower surface 30 of the superior endplate 12 defining a pocket forreceipt of the graft material. The free end 128 b of graft shield 128rests unattached on an interior ledge 12 b of superior endplate 12adjacent the distal end thereof. Opening 38 is therefore open adjacentouter surface 12 a of superior endplate 12 and closed by graft shield128 adjacent lower surface 30. As such, graft shield 128 provides abarrier between the graft material and the elevator 18 and inserts 16inserted into device 10 during expansion. Pre-packing of bone graftmaterial in opening 38 on graft shield 128 advantageously allows forless introduction of graft material in situ and provides more assurancethat sufficient graft material will be contained throughout device 10and into openings 38 and 60 through superior endplate 12 and inferiorendplates 14 and in a stress-loaded condition against opposing vertebralbodies. In addition, graft shield 128 provides a barrier substantiallypreventing graft material within opening 38 from being disturbed duringexpansion and by substantially blocking graft material from interferingwith the expansion of device 10 or with the slidable insertion ofinserts 16 which may be impeded by graft material on the slidinginterfacing surfaces.

At this point in the surgical procedure, inserter 100 is used to insertunexpanded device 10 into the intradiscal space. Device 10 may beimplanted as explained hereinabove into the spine posteriorly orposteriolaterally, either bilaterally or unilaterally, or in an anterioror lateral approach depending upon the surgical indication and thesurgeons preference. Once device 10 is inserted in the intradiscal spacein a suitable location, actuator 102 as described hereinabove is thenoperated in a first actuation. Initially during the first stroke liftingplatform 116 is translated axially while driver 124 remains stationary.Lifting platform 116 is moved from the retracted position of FIGS. 10a-bto a projecting direction whereby lifting platform 116 is moved furtherinto device 10. During movement in the projecting direction, liftingsurfaces 116 a, 116 b and 116 c of lifting platform 116 contactcooperative lifting surfaces 308 a, 312 b, and 314 b, respectively ofelevator 18. The cooperative engagement causes elevator 18 to move inthe direction of expansion away from lower inner surface 54 of inferiorendplate 14 and toward superior endplate 12. The upper surface 302 ofelevator 18 contacts lower surface 30 of superior endplate 12 andelevator 18 slidably moves in the direction of expansion along rails 14b toward superior endplate 12 and away from inferior endplate 14 asshown in FIGS. 13a-b , thereby expanding device 10.

When complete expansion of device 10 is achieved the first stroke oftrigger actuator 102 is completed and hand grips 132/134 are returned tothe original starting position, as described above. Trigger actuator 102is then operated in a second actuation to start a second stroke. As thesecond stroke commences, lifting platform 116 remains stationary holdingdevice 10 in the expanded condition while axial translation of driver124 begins. Continued operation of actuator 102 pushes insert 16distally so that the distal front end 208 moves freely into expandeddevice 10 through channel 50 until the distal front end 208 of insert 16is partially inserted into expanded device 10 between superior endplate12 and inferior endplate 14 adjacent the proximal end of device 10, asillustrated in FIGS. 13a -b.

With insert 16 partially inserted in device 10, continued operation ofthe actuator 102 during the second stroke causes lifting platform 116 tomove proximally thereby moving lifting platform 116 in a retractingdirection. With distal front end 208 of insert 16 supporting superiorendplate 12, continued proximal movement of lifting platform 116 causeslifting surfaces 116 a, 116 b and 116 c of lifting platform 116 tosufficiently disengage cooperative lifting surfaces 308 a, 312 b, and314 b, respectively of elevator 18 to allow elevator 18 to move away inthe direction of expansion from superior endplate 12 and toward inferiorendplate 14 along rails 14 b and return to the position of elevator 18shown in FIGS. 10a-b . As elevator 18 returns to the position wherebythe lower surface 120 of lifting platform 116 is situated on lower innersurface 54 of inferior endplate 14, a space like the space 64 asdescribed hereinbelow with reference to FIG. 16b , is created betweenlower surface 30 of superior endplate 12 and upper surface 302 ofelevator 18. Such space between the superior endplate 12 and theelevator 18 is slightly greater than the thickness of an insert 16 andis in direct communication with lower surface 30 of superior endplate 12and upper surface 302 of elevator 18. During completion of the secondstroke of actuator 102 driver 124 continues to move axially distallyslidably pushing insert 16 fully into such space of expanded device 10,as shown in FIG. 14, with lower surface 204 of insert 16 facing andbeing in slidable contact with upper surface 302 of elevator 18. Driver124 is retracted proximally to the original position shown in FIGS.10a-b when the hand grip 134 of actuator 102 is released.

During insertion of insert 16 into device 10, receptacle 220 describedhereinabove at the distal end 208 of insert 16 cooperatively receivescomplementary flexible latch 318 on the upper surface 302 of elevator 18such that locking surfaces 224 a, 224 b and 322 a, 322 b resilientlyinterlock, as shown in FIG. 5b . Such interlocking substantially resistsany back out of the insert 16 through channel 50 as driver 124 iswithdrawn away from insert 16 in the retracted position. In the eventdevice 10 is further expanded, as described hereinbelow, the initialinsert 16 is moved upwardly with superior endplate 12 by elevator 18. Aselevator 18 then returns downwardly toward inferior endplate 14 as willbe explained, latch 318 is separated from receptacle 220 as space 64 iscreated. With the initial insert 16 moved upwardly, it is situated abovechannel 50 and held captive by the interior surfaces of inferiorendplate 14, including interior surface 44 a of rear end wall 44. Itshould be appreciated that while insert 16 is held in position withindevice 10 by interlocking of receptacle 220 and latch 318, otherstructure to resist back out movement of insert 16 may be provided, suchas interlocking structure between insert 16 and one or more interiorsurfaces of the inferior endplate 14, or interlocking structure betweenadjacent inserts 16. Upon completion of insertion of insert 16, opening216 of insert 16 is at least partially aligned with opening 316 ofelevator 18, opening 38 of superior endplate 12 and opening 60 ofinferior endplate 14. Once inserter 100 is removed from the expandeddevice upon completion of the surgical procedure, insert opening 216,elevator opening 316 and graft chambers 38 and 60, respectively, willall be in at least partial alignment and communication with each other.

In the event the surgeon determines that additional inserts 16 arerequired in order to provide proper correction of the height of theintradiscal space, actuator 102 may be operated to insert one or moreadditional inserts 16 in the same manner as described with respect tothe insertion of first insert 16. FIGS. 15a-b show device 10 with oneinsert 16 having been inserted and a second insert 16 partiallyintroduced after device 10 has been further expanded during a firststroke of actuator 102 by elevator 18 upon lifting by the liftingplatform 116 in the same process as described with respect to FIGS.13a-b . As the second insert 16 enters the further expanded device 10during the second stroke, lifting platform 116 is pulled proximally in aretracting direction, sufficiently disengaging lifting surfaces 116 a,116 b and 116 c of lifting platform 116 from cooperative liftingsurfaces 308 a, 312 b, and 314 b, respectively of elevator 18 to allowelevator 18 to freely return to inner surface 54 of inferior endplate14. However, in the event elevator 18 fails to fully or partially returnto such position, during pushing of second insert 16 into device 10 bydriver 124, the inclined surfaces 208 a adjacent the front distal end208 of second insert 16 contacts inclined surfaces 312 a and 314 a,respectively at the upper free end of each arm 312 and 314 of elevator18, as shown in FIGS. 16a-b , to urge elevator 18 toward and againstlower surface 54 of the inferior endplate 14 creating a space 64 betweenlower surface 204 of the first insert 16 and upper surface 302 ofelevator 18. Alternatively, or in addition, a suitable biasing elementmay be included to normally urge elevator 18 toward inner surface 54 ofinferior endplate 14. Inferior endplate 14 may be formed to include alip 46 a on the front end wall 46 adjacent the distal end of cavity 48to contain a spring 107 which would serve as the biasing element, asshown, for example, in FIG. 15a . It should be understood that thefeatures urging elevator 18 toward lower inner surface 54 of inferiorendplate 14 function during the insertion of first insert 16 as well aswith all subsequently inserted inserts 16.

Continued operation of actuator 102 during the second stroke willcontinue to move second insert 16 until fully inserted shown in FIG. 17.During insertion of second insert 16 into device 10, the resilientinterlocking features of receptacle 220 described hereinabove of thesecond insert 16 cooperatively interlock with the complementaryinterlocking features of flexible latch 318 on the distal end ofelevator 18. Upon completion of insertion of second insert 16, opening216 of insert 16 is at least partially aligned with opening 216 of thefirst insert, opening 38 of superior endplate 12 and opening 60 ofinferior endplate 14, all of which will be in communication upon removalof inserter 100. The second insert 16 is the lowermost insert andresides on upper surface 302 of elevator 18 directly below and incontact with first insert 16, as shown in FIGS. 17 and 18. Driver 124 isthen again retracted proximally to the original position shown n FIGS.10a-b when the hand grip 134 of actuator 102 is released.

When the intradiscal space has been expanded to its maximum anatomicextent as the spine reaches ligamentotaxis and the device 10 cannot befurther expanded, the surgeon will be able to determine such conditionby tactile feedback. Insertion of an insert 16 into device 10 can onlybe achieved after elevator 18 reaches its ultimate movement in thedirection of expansion toward superior endplate 12. As such, failure tocompress hand grips 132/134 in a manner to complete the first stroke ofactuator 102 will allow the surgeon to recognize that ligamentotaxis hasbeen reached and the proper intradiscal height has been restored.Inasmuch as the insertion of an insert 16 follows the expansion ofdevice 10 upon full movement of elevator 18 in the direction ofexpansion toward inferior endplate 14, incomplete insertion of an insert16 may be avoided. An indication that full expansion of device 10 hasbeen reached may also be determined visually as described hereinabove byobservation that flags 162 on actuator 102 have rotated relative toframe 101. The surgeon would then terminate the procedure by actuatinghex fitting 174, as described hereinabove. Inserter 100 would then beremoved from the expanded device 10 by rotatably removing knob 112 fromthe proximal end of guide pin 108. As shown in FIG. 19, the guide pin108 may remain releasably connected to expanded device 10 to serve as alocator for subsequent attachment to an apparatus containing suitablebone graft to assist in the delivery of such material into channel 50 ofinferior endplate 14 through which inserts 16 were inserted. As such,upon removal of inserter 100 from expanded device 10, a substantiallyunobstructed path exists from channel 50 though opening 316 of elevator18 and openings 216 of inserts 16 and into openings 38 and 60 extendingthrough the superior endplate 12 and the inferior endplate 14,respectively, to allow bone graft material introduced into expandeddevice 10 through channel 50 to flow fully through device 10.

In accordance with certain specific applications of device 10 forposterior implantation as described hereinabove, the overall length ofthe device 10 as defined by the length of the inferior endplate 14 isabout 25 mm. The width of the device 10 is approximately 10 mm. Theheight of the unexpanded device 10 of FIGS. 1a-c with the superiorendplate 12 fully nested within the inferior endplate 14 isapproximately 7 mm. With the introduction of five inserts 16, each ofwhich has a thickness of approximately 1.0 mm, the height of device 10may be expanded from an unexpanded height of approximately 7 mm to anexpanded height of approximately 12 mm. It should be appreciated thatthese dimensions are only illustrative and the number of inserts 16 aswell as the dimensions of device 10 may vary depending upon theparticular surgery and application. For example, device 10 for posteriorimplantation may have an initial unexpanded height in the range ofapproximately 7-10 mm, a width in the range of approximately 10-14 mm,and a length in the range of approximately 20-35 mm, with up to eightinserts 16 for the taller sizes. For implementing such posterior-sizedevices 10, trigger actuator 102 may have an operating mechanism asdescribed herein for expanding device 10 in a first stroke and fullyinserting an insert 16 in a second stroke.

For certain applications of device 10 that may be implanted from alateral approach, device 10 may have an unexpanded height in the rangeof approximately 8-10 mm, a width in the range of approximately 14-26mm, and a length in the range of approximately 35-60 mm. To implant suchdevices 10 from the lateral approach, trigger actuator 102 may have anoperating mechanism adjusted to expand device 10 in a first stroke,partially insert an insert 16 in a second stroke, and fully insert aninsert 16 in a third stroke.

Channel 50, extending through the rear end wall 44, is sized andconfigured to facilitate the introduction of a suitable bone graftmaterial by a graft delivery apparatus that may use guide pin 108 as alocator, as shown in FIG. 19. Such a graft delivery apparatus may havean entry tip sized and configured for entry into channel 50. In aparticular arrangement, it may be desirable to increase the entryopening to further ease the delivery of graft material. In suchinstance, a portion of rear end wall 44 may be notched out to form achannel portion 50 a of increased height directly below threaded opening56. Channel portion 50 a situated below threading opening 56 woulddirect the entry flow of bone graft material into the center of expandeddevice 10. Channel portion 50 a may be suitably configured tocooperatively receive the entry tip of the graft delivery apparatus,with such channel portion 50 a being rectangular, square or arcuate. Inthe example of device 10 for posterior applications, channel portion 50a may be particularly configured to be square. Where such device 10 hasan initial unexpanded height of 7 mm and a width of 10 mm, channelportion 50 a may have a width of 3 mm and a height of 3 mm as measuredvertically from inner surface 54. In the example of device 10 forlateral applications, channel portion 50 a may be particularlyconfigured to be generally rectangular. Where such device 10 has aninitial unexpanded height of 8 mm and a width of 16 mm, channel portion50 a may have a height of 3 mm as measured vertically from inner surface54, and a width of 6 mm. For purposes of delivering bone graft materialin the form of autograft, it is desirable that the minimum dimension ofchannel portion 50 a, or any portion of channel 50 used as an entry portfor such autograft material be no less than about 2 mm. It should beappreciated, however, that depending upon the viscosity of bone graftmaterial to be delivered, such minimum dimension may vary.

Turning now to FIG. 20, an alternative inserter 400 embodying a modularconstruction is described. Inserter 400 comprises an actuator 402 and areleasable cartridge 404. Actuator 402 includes a pair of hand grips 407and 408 that are biased apart by an extension spring in the same manneras in trigger actuator 102 described hereinabove. Actuator 402 includesa frame 410 housing an operating mechanism 411 substantially the same asthe operating mechanism of trigger actuator 102. Grip 407 is fixedlysecured to frame 410 while grip 408 is pivotally connected to frame 410by a pivot pin 412. Frame 410 supports a rotatable flag 414 that iscoupled to the operating mechanism 411 as in trigger actuator 102. Frame410 includes a pair of spring-loaded flexible latches 416 projectingupwardly from an interface surface 410 a adjacent the proximal end 410 bof frame 410. Adjacent the distal end 410 c of frame 410 a supportsurface 410 d is provided. Actuator 402 in a particular embodiment isreusable. Frame 410, as well as frame 101, and hand grips 407, 408, aswell as hand grips 132, 134 are all formed of stainless steel in aparticular arrangement, although other materials, such as aluminumalloys and plastics may also be used.

Cartridge 404 comprises a track 406 contained within an outer cover 418similar to track 104 and cover 106 of trigger actuator 102. Cartridge404 likewise houses a translatable lifting platform, a translatabledriver and an indexing member (all not shown) that are constructed thesame as lifting platform 116, driver 124 and indexing member 125 oftrigger actuator 102, and that function in the same manner. A support420 comparable to support 172 is secured to the bottom of cover 418.Cartridge 404 supports a plurality of inserts 16 in a linear array forinsertion into the expandable device 10. Cooperative latching structureis provided at the bottom surface of cover 418 for releasable engagementwith latches 416 of actuator 402. In a particular embodiment, cartridge404 is disposable.

Cartridge 404 is releasably attached to frame 410 by initially engagingsupport 420 with support surface 410 d on frame 410 and then rotatingcartridge down toward proximal end 410 b until latches 416 releasablyattach to the cooperative latching structure at the bottom of cartridge404. Upon attachment of cartridge 404 with actuator 402, components ofoperating mechanism 411 interface with the driver and the liftingmechanism within track 406 in a manner comparable to actuator 102,including the receipt of boss feature 422 (the same as boss feature 156)into a slot that is the same as slot 124 d of driver 124. Cartridge 404may be released from actuator 402 by actuation of release levers 424supported by frame 410 on both sides thereof and movably coupled tolatches 416. In all other respects, modular inserter 400 operates thesame as trigger actuator 102 described hereinabove.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same should be considered asillustrative and not restrictive in character. It is understood thatonly the preferred embodiments have been presented and that all changes,modifications and further applications that come within the spirit ofthe invention are desired to be protected. For instance, an inserterwith a graft shield, such as shield 128, may be used with expandablespinal interbody fusion devices having an expansion structure without anelevator 18 as described hereinabove. For example, an inserter with agraft shield 128 may be used with the expandable interbody fusion deviceshown and described in the '312 Patent referenced hereinabove whereinthe device is expanded upon introduction of a series of wafers. Shield128 may be used similarly as described herein to provide a barrierbetween a graft opening through one of the endplates, such as thesuperior endplate, and the wafers. Such a barrier would substantiallyprevent bone graft material pre-packed into such opening frominterfering with sliding receipt of such wafers during insertion andexpansion of the device. In addition, it should also be appreciated thatactuators other than trigger actuators, such as with threaded rotarymechanisms, may be used with the inserter 100 described herein.

While one use of the invention as described herein is as an expandablespinal interbody fusion device, the invention may also be used in anysituation where it is desirable to expand two tissue surfaces and tosupport such tissue surfaces after they have been separated. The tissuemay be bone, skin, soft tissue, or combinations thereof. Further, thesurfaces may be opposed surfaces of contiguous elements or surfaces ofopposed elements. Thus, in addition to being used as a spinal interbodyfusion device as set forth herein, the invention may also be used totreat vertebral compression fractures, for replacement of vertebralbodies (VBR), as a wedge opening high tibial osteotomy, tibialtuberosity elevation, as well as for treating other compressionfractures including, but not limited to tibia plateau fractures,calcaneous, distal tibial fractures, or distal radius (wrist) fractures.One method for treating these conditions includes distracting andsupporting the tissue surfaces simultaneously, as described in the '998Patent. The approach described herein, which includes expanding thetissue and then supporting the expanded tissue, may be used to treatthese same conditions. Such procedures may be performed percutaneouslythrough a cannula or other minimally invasive instrument or in an openprocedure.

The expansion device is now described in this section by its applicationas a spinal implant to vertebral compression fractures. FIG. 21 shows avertebral body 500 having a compression fracture displacing its superiorand anterior edge 502. FIG. 22 shows vertebral body 500 wherein theheight has been restored. FIG. 23 illustrates an extrapedicular approachto vertebral body 500 wherein an access cannula 504 is placed throughthe posterolateral wall 506 of vertebral body 500. Other approaches mayoptionally be used for placing a cannula into a vertebral body such as atranspedicular approach to the vertebral body wherein an access cannulamay be placed through the pedicle. In the extrapedicular approach, twocannulae 504 may be placed bilaterally, one on each side.

The procedure for the placement of access cannula 504 into verterbralbody 500 is more fully described in the '998 Patent, incorporated hereinby reference. Cannula 504 in this particular arrangement is preferablyrectangular in cross-section, although cannulae of other cross-sections,such as circular may be used. Further, cannula 504 may be of fixedconfiguration or expandable. Once access cannula 504 is in place, anexpandable device 10 supported by inserter 100 may be introduced intovertebral body 500 through cannula 504. This application of theinvention contemplates expanding expandable device 10 by the inserter100 from an unexpanded condition as shown, for example in FIG. 3a to theexpanded height as shown in FIG. 24 to ultimately reduce the vertebralcompression fracture and substantially restore the normal anatomicheight of vertebral body 500, inserting one or more inserts, such asinserts 16, as described herein, to form a stack of inserts 16 betweenthe expanded superior endplate 12 and inferior endplate 14 of expandabledevice 10. In the particular arrangement being described for vertebralcompression fracture reduction, expandable device 10 may have a lengthof approximately 25 mm, a width of approximately 10 mm, and anunexpanded height H of approximately 7 mm. The height H may be expandedby 5 mm and supported by the introduction of five inserts 16, as shownin FIG. 24, each insert 16 as described herein having a thickness of 1mm. It should be appreciated that the height H may be increased by otheramounts and more or less than five inserts used, and that device 10 maybe configured in other dimensions as set forth in the '998 Patent.

When the fracture is reduced as depicted in FIG. 22, or when thephysician determines that an adequate number of inserts 16 has beeninserted, the inserter 100 may be ‘separated from device 10 and removedfrom cannula 504 while expanded device 10 remains within vertebral body500. Access cannula 504 is left in place. Suitable bone filler may beinjected into vertebral body 500 through cannula 504 to encapsulatedevice 10, provide weight bearing structure and increase stability ofvertebral body 500. Bone filler may flow through device 10 and theinsert column and out to the surrounding bone to interdigitate withcancellous bone.

It should therefore be understood that while various embodiments of theinvention have been presented herein, various changes, modifications andfurther applications may be made without departing from the spirit ofthe invention and the scope of the appended claims.

What is claimed is:
 1. An inserter for expanding an expandable devicefor expanding body tissue and inserting an insert into said device,comprising: an elongate frame; an elongate lifting platform supported bysaid frame for axial movement thereon for expanding said device, saidlifting platform including a lifting surface for engaging acooperatively configured receiving surface of said device to expand saiddevice; an elongate driver movably supported by said frame for axialmovement thereon for inserting said insert into said device; an actuatorsupported by said frame and operably coupled to said lifting platformand said driver to cause axial movement of said driver and said liftingplatform upon operation of said actuator; and a movable indicatorcoupled to said elongate driver for movement therewith and exteriorlysupported by said frame for movement thereon, movement of said indicatorproviding a visual indication of expansion of said device.
 2. Theinserter of claim 1, wherein said driver moves at least partiallyindependently of axial movement of said elongate lifting platform uponoperation of said actuator.
 3. The inserter of claim 1, wherein saidindicator comprises a flag that is rotatable relative to said frame,rotation of said flag indicating expansion of said device.
 4. Theinserter of claim 1, wherein said indicator is operable independently ofsaid actuator to move said driver in a retracting direction to a resetposition relative to said frame.
 5. The inserter of claim 1, furtherincluding an elongate track having a distal end and a proximal end, saiddriver being supported by said track for axial movement for contactingand driving said insert into said device.
 6. The inserter of claim 5,wherein said track is configured to linearly support a plurality ofinserts for sequential individual insertion into said device by saiddriver.
 7. The inserter of claim 1, further comprising a guide pinreleasably connectable to said device and detachably connected to saidframe.
 8. The inserter of claim 1, wherein said inserter furthercomprises a graft shield projecting from the distal end of said inserterand being of size and configuration to extend into said device.
 9. Theinserter of claim 1, wherein said actuator comprises a pair of handgrips, one of which is fixedly secured to said frame and the other ofwhich is pivotally connected to said frame.
 10. An inserter forexpanding an expandable device for expanding body tissue and insertingan insert into said device, comprising: an actuator including a frameand an operating mechanism; and an elongate cartridge releasablyconnected to said frame, said cartridge including an elongate trackmovably supporting an elongate lifting platform for expanding saiddevice and supporting for movement at least partially independently ofsaid lifting platform an elongate driver for inserting an insert intosaid device, and a plurality of inserts in a linear array, saidcartridge being disposed on said frame such that said lifting platformand said driver are operably separably connected to said operatingmechanism.
 11. The inserter of claim 10, wherein said cartridge isdisposable.
 12. The inserter of claim 11, wherein said actuator isreusable.
 13. The inserter of claim 10, wherein said actuator framecomprises a flexible latch for releasable connection to said cartridge.14. The inserter of claim 13, wherein said frame includes a movablelever for actuation of said flexible latch and release of said cartridgefrom said frame.
 15. The inserter of claim 10, wherein said actuatorcomprises a pair of hand grips, one grip being fixedly secured to saidframe and the other grip being pivotally connected to said frame andspring-loaded relative to said one grip.
 16. The inserter of claim 10,further comprising a movable indicator coupled to said operatingmechanism and exteriorly supported by said frame for movement thereonwith said driver, movement of said indicator providing a visualindication of expansion of said device.
 17. The inserter of claim 16,wherein said indicator comprises a flag that is rotatable relative tosaid frame, rotation of said flag indicating expansion of said device.18. An inserter for expanding an expandable device for expanding bodytissue and inserting an insert into said device, comprising: an elongateframe; an elongate lifting platform supported by said frame for axialmovement thereon for expanding said device, said lifting platformincluding a lifting surface for engaging a cooperatively configuredreceiving surface of said device to expand said device; an elongatedriver movably supported by said frame for axial movement thereon forinserting said insert into said device; an actuator supported by saidframe and operably coupled to said lifting platform and said driver tocause axial movement of said driver and said lifting platform uponoperation of said actuator; and an expansion release member coupled tosaid lifting platform and operable independently of said actuator tomove said lifting platform in a retracting direction.
 19. The inserterof claim 18, wherein said expansion release member is a fittingexteriorly supported by said frame.
 20. The inserter of claim 19,wherein said fitting is rotatable.
 21. An inserter for expanding anexpandable device for expanding body tissue and inserting an insert intosaid device, comprising: an actuator including a frame and an operatingmechanism, said operating mechanism comprising a movable expansionelement movable upon operation of said actuator and engageable with saiddevice for expanding said device; and a movable indicator exteriorlysupported by said frame for movement thereon and responsive to themovement of said expansion element for providing a visual indication ofexpansion of said device.
 22. The inserter of claim 21, furtherincluding an expansion release member coupled to said movable expansionmember and exteriorly supported by said frame, said expansion releasemember being coupled to said expansion release member and operable tomove said expansion element independently of operation of said actuator.